Trial Outcomes & Findings for Prebiotic Treatment in People With Schizophrenia - Pilot Study (NCT NCT03617783)

Last Updated: 2023-06-15

Results Overview

We will use the following procedure to assess the effect of Prebiotin (OEI) on serum butyrate levels: there will be two test days: a) baseline (Day 0), prior to randomization to OEI or placebo; and b) Day 11, following the 10 day course of OEI/placebo treatment. We will use OEI for the inulin challenge. On the night prior to each test day, participants will receive a digestable and non-fermentable meal, e.g. lasagna. They will then fast from midnight until the morning, when they will receive their standard breakfast and OEI, 12g. We will collect fasting and 6-hour blood samples from each participant. The Day 11 change in serum butyrate levels following the OEI challenge dose (6-hour minus fasting serum butyrate level) will be compared to the Day 0 change in serum butyrate levels to determine whether the 10-day OEI treatment regimen modified the hypothesized biological signature through increased activity of butyrate-producing bacteria. Serum butyrate will be quantified by LC-MS/MS.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

26 participants

Primary outcome timeframe

11 days

Results posted on

2023-06-15

Participant Flow

Four (4) participants were excluded/withdrawn prior to the initiation of study medication: one participant was excluded due to their BMI being greater than 35; one participant was excluded due to starting on an antibiotic; one participant was withdrawn because we were unable to obtain a baseline butyrate level; and one participant was discharged from the inpatient unit.

Participant milestones

Participant milestones
Measure	Prebiotin Prebiotin: Prebiotin (12g/day), an oligofructose-enriched inulin (OEI)	Placebo Placebo: placebo-OEI
Overall Study STARTED	9	13
Overall Study COMPLETED	8	12
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prebiotic Treatment in People With Schizophrenia - Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prebiotin n=9 Participants Prebiotin: Prebiotin (12g/day), an oligofructose-enriched inulin (OEI)	Placebo n=13 Participants Placebo: placebo-OEI	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	13 participants n=7 Participants	22 participants n=5 Participants
Pre-Treatment Baseline Butyrate Level	2.42 mg/ml STANDARD_DEVIATION 0.52 • n=5 Participants	2.34 mg/ml STANDARD_DEVIATION 0.77 • n=7 Participants	2.37 mg/ml STANDARD_DEVIATION 0.67 • n=5 Participants

PRIMARY outcome

Timeframe: 11 days

Population: Two participants were withdrawn from the treatment phase of the study: we were unable to obtain the second challenge day butyrate levels (n=1); refusal to continue in the study (n=1).

Outcome measures

Outcome measures
Measure	Prebiotin n=9 Participants Prebiotin: Prebiotin (12g/day), an oligofructose-enriched inulin (OEI)	Placebo n=13 Participants Placebo: placebo-OEI
Change in Serum Butyrate Levels Pre-Treatment Butyrate Level	2.42 mg/ml Standard Deviation 0.52	2.34 mg/ml Standard Deviation 0.77
Change in Serum Butyrate Levels Post-Treatment Butyrate Level	2.88 mg/ml Standard Deviation 1.02	2.40 mg/ml Standard Deviation 0.93

Adverse Events

Prebiotin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Prebiotin n=9 participants at risk Prebiotin: Prebiotin (12g/day), an oligofructose-enriched inulin (OEI)	Placebo n=13 participants at risk Placebo: placebo-OEI
Renal and urinary disorders urinary tract infection	11.1% 1/9 • Number of events 1 • 10 days	0.00% 0/13 • 10 days
General disorders headache	0.00% 0/9 • 10 days	7.7% 1/13 • Number of events 1 • 10 days
Gastrointestinal disorders diarrhea	0.00% 0/9 • 10 days	7.7% 1/13 • Number of events 1 • 10 days

Additional Information

Dr. Robert Buchanan

Maryland Psychiatric Research Center

Phone: 410-402-7876

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place